Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
Sponsor
FibroGen (Industry)
Overall Status
Completed
CT.gov ID
NCT01244763
Collaborator
Astellas Pharma Inc (Industry)
145
38
6
19.5
3.8
0.2
Study Details
Study Description
Brief Summary
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
145 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Open-Label, Dose Titration, Efficacy and Safety Study of FG-4592 (Roxadustat) in Non-Dialysis Chronic Kidney Disease Patients With Anemia
Actual Study Start Date
:
Oct 29, 2010
Actual Primary Completion Date
:
Jun 13, 2012
Actual Study Completion Date
:
Jun 13, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A: Roxadustat Tiered, Weight Based Dosing TIW Participants will receive roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kilograms (kg)], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants will receive 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. |
Drug: Roxadustat
Oral capsule
Other Names:
|
| Experimental: Cohort B: Roxadustat Tiered, Weight Based Dosing TIW then BIW Participants will receive roxadustat capsules orally for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants will receive 60, 100, and 140 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response. |
Drug: Roxadustat
Oral capsule
Other Names:
|
| Experimental: Cohort C: Roxadustat at 50 mg TIW Participants will receive roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. |
Drug: Roxadustat
Oral capsule
Other Names:
|
| Experimental: Cohort D: Roxadustat at 100 mg TIW Participants will receive roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. |
Drug: Roxadustat
Oral capsule
Other Names:
|
| Experimental: Cohort E: Roxadustat Tiered, Weight Based Dosing BIW then QW Participants will receive roxadustat capsules for 24 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants will receive 70, 100, and 150 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response. |
Drug: Roxadustat
Oral capsule
Other Names:
|
| Experimental: Cohort F: Roxadustat at 70 mg BIW then QW Participants will receive roxadustat capsules at 70 mg for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency will be reduced from BIW to QW. |
Drug: Roxadustat
Oral capsule
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number (%) of Participants With an Hb Response by Week 17 [Up to Week 17]
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
Secondary Outcome Measures
- Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 [Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)]
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
- Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 [Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)]
Baseline is defined as the mean of the last 3 available values predose.
- Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 [Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)]
Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive.
- Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 [Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)]
- Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 [Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)]
Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks.
- Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 [Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)]
- Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL [Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)]
Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.
- Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline [Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)]
Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.
- Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline [Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)]
- Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week [Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment)]
- Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories [Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment])]
- Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 [Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)]
The mean percentage of the scheduled weekly Hb values that were <10.5, >13, and >14 g/dL during Weeks 13-17 and 18-25 is presented.
- Number (%) of Participants Requiring Rescue Therapy [Baseline up to Week 28 (end of study)]
Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron
- Number (%) of Participants Requiring Therapeutic Phlebotomy [Baseline up to Week 28 (end of study)]
- Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy [Baseline up to Week 28 (end of study)]
- Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 [Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)]
Dose changes include dose reductions, dose increases, and dose holds.
- Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) [Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)]
- Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) [Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)]
- Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 [Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)]
Baseline was defined as the mean of the last 3 available values predose.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 18 to 75 years
-
Chronic kidney disease, not receiving dialysis
-
Body weight 45 to 140 kg
Exclusion Criteria:
-
Any clinically significant infection or evidence of an underlying infection
-
Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
-
History of chronic liver disease
-
New York Heart Association Class III or IV congestive heart failure
-
Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
-
History of malignancy
-
Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
-
History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
-
History of hemosiderosis, hemochromatosis or polycystic kidney disease
-
Active hemolysis or diagnosis of hemolytic syndrome
-
Uncontrolled or symptomatic secondary hyperparathyroidism
-
Seizure disorder or receiving anti-epilepsy medication
-
Known bone marrow fibrosis
-
Any prior or scheduled organ transplant
-
Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
-
History of alcohol or drug abuse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mobile | Alabama | United States | ||
| 2 | Pine Bluff | Arkansas | United States | ||
| 3 | Azusa | California | United States | ||
| 4 | Chula Vista | California | United States | ||
| 5 | Downey | California | United States | ||
| 6 | Northridge | California | United States | ||
| 7 | Paramount | California | United States | ||
| 8 | Riverside | California | United States | ||
| 9 | Whittier | California | United States | ||
| 10 | Yuba City | California | United States | ||
| 11 | Fort Lauderdale | Florida | United States | ||
| 12 | Lauderdale Lakes | Florida | United States | ||
| 13 | Pembroke Pines | Florida | United States | ||
| 14 | Tampa | Florida | United States | ||
| 15 | Augusta | Georgia | United States | ||
| 16 | Meridian | Idaho | United States | ||
| 17 | Wichita | Kansas | United States | ||
| 18 | Baton Rouge | Louisiana | United States | ||
| 19 | Shreveport | Louisiana | United States | ||
| 20 | Bethesda | Maryland | United States | ||
| 21 | Detroit | Michigan | United States | ||
| 22 | Lincoln | Nebraska | United States | ||
| 23 | Mount Laurel | New Jersey | United States | ||
| 24 | Mineola | New York | United States | ||
| 25 | New York | New York | United States | ||
| 26 | Asheville | North Carolina | United States | ||
| 27 | Raleigh | North Carolina | United States | ||
| 28 | Canton | Ohio | United States | ||
| 29 | Orangeburg | South Carolina | United States | ||
| 30 | Knoxville | Tennessee | United States | ||
| 31 | Arlington | Texas | United States | ||
| 32 | Fort Worth | Texas | United States | ||
| 33 | Houston | Texas | United States | ||
| 34 | San Antonio | Texas | United States | ||
| 35 | Fairfax | Virginia | United States | ||
| 36 | Caguas | Puerto Rico | |||
| 37 | Ponce | Puerto Rico | |||
| 38 | San Juan | Puerto Rico |
Sponsors and Collaborators
- FibroGen
- Astellas Pharma Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
FibroGen
ClinicalTrials.gov Identifier:
NCT01244763
Other Study ID Numbers:
- FGCL-4592-041
First Posted:
Nov 19, 2010
Last Update Posted:
Feb 10, 2022
Last Verified:
Jan 1, 2022
Keywords provided by FibroGen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kilograms (kg)], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Period Title: Overall Study | ||||||
| STARTED | 24 | 24 | 24 | 24 | 24 | 25 |
| Safety Population | 24 | 24 | 24 | 24 | 24 | 25 |
| Efficacy Evaluable (EE) Population | 23 | 24 | 23 | 24 | 24 | 25 |
| COMPLETED | 21 | 21 | 22 | 23 | 21 | 21 |
| NOT COMPLETED | 3 | 3 | 2 | 1 | 3 | 4 |
Baseline Characteristics
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. | Total of all reporting groups |
| Overall Participants | 24 | 24 | 24 | 24 | 24 | 25 | 145 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
65.9
(9.3)
|
64.3
(10.3)
|
59.2
(14.7)
|
69.8
(8.0)
|
61.8
(13.2)
|
65.2
(8.6)
|
64.4
(11.3)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
19
79.2%
|
17
70.8%
|
16
66.7%
|
11
45.8%
|
16
66.7%
|
13
52%
|
92
63.4%
|
| Male |
5
20.8%
|
7
29.2%
|
8
33.3%
|
13
54.2%
|
8
33.3%
|
12
48%
|
53
36.6%
|
| Hb (g/dL) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [g/dL] |
9.56
(0.86)
|
9.67
(0.62)
|
9.80
(0.49)
|
9.68
(0.77)
|
9.89
(0.60)
|
9.72
(0.60)
|
9.72
(0.66)
|
Outcome Measures
| Title | Number (%) of Participants With an Hb Response by Week 17 |
|---|---|
| Description | An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL. |
| Time Frame | Up to Week 17 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Count of Participants [Participants] |
19
79.2%
|
24
100%
|
21
87.5%
|
23
95.8%
|
23
95.8%
|
21
84%
|
| Title | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 |
|---|---|
| Description | An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL. |
| Time Frame | Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Week 5 |
15
62.5%
|
14
58.3%
|
3
12.5%
|
13
54.2%
|
9
37.5%
|
9
36%
|
| Week 9 |
18
75%
|
21
87.5%
|
12
50%
|
20
83.3%
|
18
75%
|
13
52%
|
| Week 13 |
18
75%
|
23
95.8%
|
15
62.5%
|
21
87.5%
|
20
83.3%
|
16
64%
|
| Week 17 |
19
79.2%
|
24
100%
|
17
70.8%
|
22
91.7%
|
23
95.8%
|
20
80%
|
| Week 21 |
19
79.2%
|
22
91.7%
|
23
95.8%
|
21
87.5%
|
||
| Week 25 |
21
87.5%
|
23
95.8%
|
23
95.8%
|
21
87.5%
|
| Title | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 |
|---|---|
| Description | Baseline is defined as the mean of the last 3 available values predose. |
| Time Frame | Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Baseline |
9.56
(0.88)
|
9.67
(0.62)
|
9.80
(0.50)
|
9.68
(0.77)
|
9.89
(0.60)
|
9.72
(0.60)
|
| Change at Week 5 |
1.71
(1.02)
|
1.11
(0.96)
|
0.57
(0.65)
|
1.65
(0.95)
|
0.74
(0.75)
|
0.63
(0.85)
|
| Change at Week 9 |
2.58
(0.97)
|
1.77
(1.18)
|
0.99
(0.87)
|
2.21
(1.02)
|
1.67
(0.98)
|
0.89
(1.23)
|
| Change at Week 13 |
2.46
(0.93)
|
2.06
(1.07)
|
1.26
(1.09)
|
2.17
(1.19)
|
1.43
(0.90)
|
1.19
(1.10)
|
| Change at Week 17 |
2.63
(0.83)
|
2.28
(0.87)
|
1.43
(1.15)
|
2.26
(1.31)
|
1.50
(0.73)
|
1.46
(1.23)
|
| Change at Week 21 |
1.30
(0.97)
|
1.94
(0.81)
|
1.19
(1.08)
|
1.79
(0.77)
|
||
| Change at Week 25 |
1.33
(1.00)
|
1.73
(1.14)
|
1.28
(1.08)
|
1.51
(1.06)
|
| Title | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 |
|---|---|
| Description | Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive. |
| Time Frame | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Weeks 5-8, HB Value of 11-12 g/dL |
4
16.7%
|
11
45.8%
|
7
29.2%
|
8
33.3%
|
10
41.7%
|
7
28%
|
| Weeks 5-8, HB Value of 11-13 g/dL |
13
54.2%
|
14
58.3%
|
7
29.2%
|
12
50%
|
13
54.2%
|
8
32%
|
| Weeks 5-8, HB Value of 10.5-13 g/dL |
16
66.7%
|
18
75%
|
14
58.3%
|
16
66.7%
|
17
70.8%
|
13
52%
|
| Weeks 9-12, HB Value of 11-12 g/dL |
5
20.8%
|
12
50%
|
7
29.2%
|
8
33.3%
|
9
37.5%
|
6
24%
|
| Weeks 9-12, HB Value of 11-13 g/dL |
13
54.2%
|
18
75%
|
9
37.5%
|
16
66.7%
|
12
50%
|
10
40%
|
| Weeks 9-12, HB Value of 10.5-13 g/dL |
14
58.3%
|
21
87.5%
|
16
66.7%
|
17
70.8%
|
16
66.7%
|
15
60%
|
| Weeks 9-16, HB Value of 11-12 g/dL |
6
25%
|
11
45.8%
|
8
33.3%
|
8
33.3%
|
11
45.8%
|
7
28%
|
| Weeks 9-16, HB Value of 11-13 g/dL |
12
50%
|
19
79.2%
|
11
45.8%
|
16
66.7%
|
14
58.3%
|
11
44%
|
| Weeks 9-16, HB Value of 10.5-13 g/dL |
14
58.3%
|
22
91.7%
|
15
62.5%
|
19
79.2%
|
20
83.3%
|
17
68%
|
| Weeks 13-16, HB Value of 11-12 g/dL |
6
25%
|
10
41.7%
|
9
37.5%
|
9
37.5%
|
14
58.3%
|
9
36%
|
| Weeks 13-16, HB Value of 11-13 g/dL |
11
45.8%
|
19
79.2%
|
10
41.7%
|
17
70.8%
|
17
70.8%
|
13
52%
|
| Weeks 13-16, HB Value of 10.5-13 g/dL |
13
54.2%
|
21
87.5%
|
14
58.3%
|
19
79.2%
|
20
83.3%
|
18
72%
|
| Weeks 17-20, HB Value of 11-12 g/dL |
4
16.7%
|
9
37.5%
|
9
37.5%
|
11
45.8%
|
9
37.5%
|
9
36%
|
| Weeks 17-20, HB Value of 11-13 g/dL |
10
41.7%
|
18
75%
|
11
45.8%
|
20
83.3%
|
11
45.8%
|
16
64%
|
| Weeks 17-20, HB Value of 10.5-13 g/dL |
11
45.8%
|
19
79.2%
|
17
70.8%
|
20
83.3%
|
17
70.8%
|
19
76%
|
| Weeks 17-24, HB Value of 11-12 g/dL |
12
50%
|
14
58.3%
|
11
45.8%
|
11
45.8%
|
||
| Weeks 17-24, HB Value of 11-13 g/dL |
13
54.2%
|
20
83.3%
|
12
50%
|
17
70.8%
|
||
| Weeks 17-24, HB Value of 10.5-13 g/dL |
18
75%
|
22
91.7%
|
15
62.5%
|
21
87.5%
|
||
| Weeks 21-24, HB Value of 11-12 g/dL |
11
45.8%
|
13
54.2%
|
7
29.2%
|
14
58.3%
|
||
| Weeks 21-24, HB Value of 11-13 g/dL |
13
54.2%
|
18
75%
|
9
37.5%
|
18
75%
|
||
| Weeks 21-24, HB Value of 10.5-13 g/dL |
19
79.2%
|
21
87.5%
|
13
54.2%
|
20
83.3%
|
||
| Weeks 25-28, HB Value of 11-12 g/dL |
10
41.7%
|
8
33.3%
|
6
25%
|
12
50%
|
||
| Weeks 25-28, HB Value of 11-13 g/dL |
11
45.8%
|
11
45.8%
|
9
37.5%
|
13
54.2%
|
||
| Weeks 25-28, HB Value of 10.5-13 g/dL |
16
66.7%
|
19
79.2%
|
14
58.3%
|
17
70.8%
|
| Title | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 |
|---|---|
| Description | |
| Time Frame | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Weeks 5-8, Hb Value of 11-12 g/dL |
4
16.7%
|
11
45.8%
|
5
20.8%
|
9
37.5%
|
8
33.3%
|
4
16%
|
| Weeks 5-8, Hb Value of 11-13 g/dL |
13
54.2%
|
14
58.3%
|
8
33.3%
|
12
50%
|
12
50%
|
6
24%
|
| Weeks 5-8, Hb Value of 10.5-13 g/dL |
15
62.5%
|
17
70.8%
|
14
58.3%
|
16
66.7%
|
16
66.7%
|
13
52%
|
| Weeks 9-12, Hb Value of 11-12 g/dL |
5
20.8%
|
12
50%
|
7
29.2%
|
8
33.3%
|
10
41.7%
|
8
32%
|
| Weeks 9-12, Hb Value of 11-13 g/dL |
12
50%
|
17
70.8%
|
10
41.7%
|
16
66.7%
|
12
50%
|
11
44%
|
| Weeks 9-12, Hb Value of 10.5-13 g/dL |
14
58.3%
|
21
87.5%
|
16
66.7%
|
18
75%
|
17
70.8%
|
15
60%
|
| Weeks 9-16, Hb Value of 11-12 g/dL |
8
33.3%
|
16
66.7%
|
10
41.7%
|
10
41.7%
|
15
62.5%
|
11
44%
|
| Weeks 9-16, Hb Value of 11-13 g/dL |
14
58.3%
|
22
91.7%
|
13
54.2%
|
20
83.3%
|
18
75%
|
15
60%
|
| Weeks 9-16, Hb Value of 10.5-13 g/dL |
16
66.7%
|
23
95.8%
|
19
79.2%
|
20
83.3%
|
22
91.7%
|
18
72%
|
| Weeks 13-16, Hb Value of 11-12 g/dL |
7
29.2%
|
11
45.8%
|
9
37.5%
|
7
29.2%
|
13
54.2%
|
7
28%
|
| Weeks 13-16, Hb Value of 11-13 g/dL |
12
50%
|
19
79.2%
|
12
50%
|
15
62.5%
|
17
70.8%
|
13
52%
|
| Weeks 13-16, Hb Value of 10.5-13 g/dL |
13
54.2%
|
20
83.3%
|
17
70.8%
|
16
66.7%
|
20
83.3%
|
17
68%
|
| Weeks 17-20, Hb Value of 11-12 g/dL |
0
0%
|
0
0%
|
10
41.7%
|
10
41.7%
|
9
37.5%
|
8
32%
|
| Weeks 17-20, Hb Value of 11-13 g/dL |
0
0%
|
0
0%
|
12
50%
|
19
79.2%
|
12
50%
|
14
56%
|
| Weeks 17-20, Hb Value of 10.5-13 g/dL |
0
0%
|
0
0%
|
16
66.7%
|
20
83.3%
|
18
75%
|
20
80%
|
| Weeks 17-24, Hb Value of 11-12 g/dL |
14
58.3%
|
17
70.8%
|
14
58.3%
|
17
70.8%
|
||
| Weeks 17-24, Hb Value of 11-13 g/dL |
16
66.7%
|
22
91.7%
|
14
58.3%
|
20
83.3%
|
||
| Weeks 17-24, Hb Value of 10.5-13 g/dL |
20
83.3%
|
22
91.7%
|
18
75%
|
22
91.7%
|
||
| Weeks 21-24, Hb Value of 11-12 g/dL |
12
50%
|
12
50%
|
10
41.7%
|
15
62.5%
|
||
| Weeks 21-24, Hb Value of 11-13 g/dL |
15
62.5%
|
18
75%
|
11
45.8%
|
18
75%
|
||
| Weeks 21-24, Hb Value of 10.5-13 g/dL |
20
83.3%
|
21
87.5%
|
14
58.3%
|
21
87.5%
|
||
| Weeks 25-28, Hb Value of 11-12 g/dL |
5
20.8%
|
9
37.5%
|
4
16.7%
|
8
33.3%
|
||
| Weeks 25-28, Hb Value of 11-13 g/dL |
8
33.3%
|
13
54.2%
|
7
29.2%
|
12
50%
|
||
| Weeks 25-28, Hb Value of 10.5-13 g/dL |
13
54.2%
|
19
79.2%
|
14
58.3%
|
16
66.7%
|
| Title | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 |
|---|---|
| Description | Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks. |
| Time Frame | Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Hb Value of 11-12 g/dL by Week 5 |
9
37.5%
|
11
45.8%
|
5
20.8%
|
8
33.3%
|
11
45.8%
|
10
40%
|
| Hb Value of 11-12 g/dL by Week 9 |
11
45.8%
|
16
66.7%
|
11
45.8%
|
11
45.8%
|
15
62.5%
|
14
56%
|
| Hb Value of 11-12 g/dL by Week 13 |
11
45.8%
|
19
79.2%
|
14
58.3%
|
13
54.2%
|
17
70.8%
|
17
68%
|
| Hb Value of 11-12 g/dL by Week 17 |
12
50%
|
20
83.3%
|
16
66.7%
|
14
58.3%
|
17
70.8%
|
20
80%
|
| Hb Value of 11-12 g/dL by Week 21 |
17
70.8%
|
15
62.5%
|
19
79.2%
|
22
91.7%
|
||
| Hb Value of 11-12 g/dL by Week 25 |
21
87.5%
|
18
75%
|
20
83.3%
|
22
91.7%
|
||
| Hb Value of 11-13 g/dL by Week 5 |
16
66.7%
|
14
58.3%
|
6
25%
|
14
58.3%
|
13
54.2%
|
10
40%
|
| Hb Value of 11-13 g/dL by Week 9 |
18
75%
|
21
87.5%
|
14
58.3%
|
19
79.2%
|
18
75%
|
14
56%
|
| Hb Value of 11-13 g/dL by Week 13 |
18
75%
|
23
95.8%
|
17
70.8%
|
21
87.5%
|
21
87.5%
|
17
68%
|
| Hb Value of 11-13 g/dL by Week 17 |
19
79.2%
|
24
100%
|
19
79.2%
|
22
91.7%
|
23
95.8%
|
21
84%
|
| Hb Value of 11-13 g/dL by Week 21 |
20
83.3%
|
22
91.7%
|
23
95.8%
|
22
91.7%
|
||
| Hb Value of 11-13 g/dL by Week 25 |
22
91.7%
|
23
95.8%
|
23
95.8%
|
22
91.7%
|
||
| Hb Value of 10.5-13 g/dL by Week 5 |
17
70.8%
|
20
83.3%
|
12
50%
|
17
70.8%
|
17
70.8%
|
14
56%
|
| Hb Value of 10.5-13 g/dL by Week 9 |
19
79.2%
|
22
91.7%
|
19
79.2%
|
21
87.5%
|
19
79.2%
|
19
76%
|
| Hb Value of 10.5-13 g/dL by Week 13 |
19
79.2%
|
23
95.8%
|
20
83.3%
|
23
95.8%
|
22
91.7%
|
21
84%
|
| Hb Value of 10.5-13 g/dL by Week 17 |
20
83.3%
|
24
100%
|
21
87.5%
|
23
95.8%
|
23
95.8%
|
23
92%
|
| Hb Value of 10.5-13 g/dL by Week 21 |
22
91.7%
|
24
100%
|
23
95.8%
|
23
95.8%
|
||
| Hb Value of 10.5-13 g/dL by Week 25 |
23
95.8%
|
24
100%
|
23
95.8%
|
24
100%
|
| Title | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 |
|---|---|
| Description | |
| Time Frame | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Weeks 5-8, Hb Value of <11 g/dL |
6
25%
|
9
37.5%
|
10
41.7%
|
5
20.8%
|
6
25%
|
13
52%
|
| Weeks 5-8, Hb Value of 12-13 g/dL |
10
41.7%
|
6
25%
|
4
16.7%
|
6
25%
|
4
16.7%
|
3
12%
|
| Weeks 5-8, Hb Value of 13-14 g/dL |
2
8.3%
|
1
4.2%
|
0
0%
|
3
12.5%
|
1
4.2%
|
0
0%
|
| Weeks 5-8, Hb Value of >14 g/dL |
1
4.2%
|
0
0%
|
0
0%
|
1
4.2%
|
0
0%
|
0
0%
|
| Weeks 9-12, Hb Value of <11 g/dL |
4
16.7%
|
2
8.3%
|
9
37.5%
|
4
16.7%
|
7
29.2%
|
11
44%
|
| Weeks 9-12, Hb Value of 12-13 g/dL |
5
20.8%
|
9
37.5%
|
4
16.7%
|
8
33.3%
|
6
25%
|
6
24%
|
| Weeks 9-12, Hb Value of 13-14 g/dL |
7
29.2%
|
1
4.2%
|
1
4.2%
|
3
12.5%
|
3
12.5%
|
0
0%
|
| Weeks 9-12, Hb Value of >14 g/dL |
2
8.3%
|
1
4.2%
|
0
0%
|
2
8.3%
|
0
0%
|
0
0%
|
| Weeks 9-16, Hb Value of <11 g/dL |
4
16.7%
|
1
4.2%
|
7
29.2%
|
1
4.2%
|
2
8.3%
|
7
28%
|
| Weeks 9-16, Hb Value of 12-13 g/dL |
4
16.7%
|
10
41.7%
|
5
20.8%
|
8
33.3%
|
9
37.5%
|
8
32%
|
| Weeks 9-16, Hb Value of 13-14 g/dL |
7
29.2%
|
4
16.7%
|
2
8.3%
|
6
25%
|
3
12.5%
|
1
4%
|
| Weeks 9-16, Hb Value of >14 g/dL |
4
16.7%
|
1
4.2%
|
0
0%
|
3
12.5%
|
0
0%
|
0
0%
|
| Weeks 13-16, Hb Value of <11 g/dL |
5
20.8%
|
2
8.3%
|
9
37.5%
|
1
4.2%
|
3
12.5%
|
7
28%
|
| Weeks 13-16, Hb Value of 12-13 g/dL |
4
16.7%
|
9
37.5%
|
4
16.7%
|
8
33.3%
|
7
29.2%
|
7
28%
|
| Weeks 13-16, Hb Value of 13-14 g/dL |
6
25%
|
4
16.7%
|
2
8.3%
|
7
29.2%
|
3
12.5%
|
1
4%
|
| Weeks 13-16, Hb Value of >14 g/dL |
2
8.3%
|
0
0%
|
0
0%
|
1
4.2%
|
0
0%
|
0
0%
|
| Weeks 17-20, Hb Value of <11 g/dL |
4
16.7%
|
3
12.5%
|
5
20.8%
|
2
8.3%
|
3
12.5%
|
4
16%
|
| Weeks 17-20, Hb Value of 12-13 g/dL |
6
25%
|
9
37.5%
|
4
16.7%
|
10
41.7%
|
5
20.8%
|
5
20%
|
| Weeks 17-20, Hb Value of 13-14 g/dL |
6
25%
|
3
12.5%
|
1
4.2%
|
6
25%
|
0
0%
|
2
8%
|
| Weeks 17-20, Hb Value of >14 g/dL |
1
4.2%
|
0
0%
|
0
0%
|
0
0%
|
1
4.2%
|
0
0%
|
| Weeks 17-24, Hb Value of <11 g/dL |
2
8.3%
|
0
0%
|
3
12.5%
|
3
12.5%
|
||
| Weeks 17-24, Hb Value of 12-13 g/dL |
8
33.3%
|
13
54.2%
|
6
25%
|
7
29.2%
|
||
| Weeks 17-24, Hb Value of 13-14 g/dL |
1
4.2%
|
6
25%
|
0
0%
|
4
16.7%
|
||
| Weeks 17-24, Hb Value of >14 g/dL |
0
0%
|
0
0%
|
1
4.2%
|
0
0%
|
||
| Weeks 21-24, Hb Value of <11 g/dL |
2
8.3%
|
1
4.2%
|
9
37.5%
|
4
16.7%
|
||
| Weeks 21-24, Hb Value of 12-13 g/dL |
6
25%
|
10
41.7%
|
3
12.5%
|
7
29.2%
|
||
| Weeks 21-24, Hb Value of 13-14 g/dL |
1
4.2%
|
1
4.2%
|
1
4.2%
|
3
12.5%
|
||
| Weeks 21-24, Hb Value of >14 g/dL |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||
| Weeks 25-28, Hb Value of <11 g/dL |
7
29.2%
|
6
25%
|
7
29.2%
|
8
33.3%
|
||
| Weeks 25-28, Hb Value of 12-13 g/dL |
4
16.7%
|
4
16.7%
|
4
16.7%
|
3
12.5%
|
||
| Weeks 25-28, Hb Value of 13-14 g/dL |
0
0%
|
1
4.2%
|
0
0%
|
1
4.2%
|
||
| Weeks 25-28, Hb Value of >14 g/dL |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL |
|---|---|
| Description | Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved. |
| Time Frame | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Median (Full Range) [days] |
28.0
|
28.0
|
48.9
|
28.0
|
35.0
|
56.0
|
| Title | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline |
|---|---|
| Description | Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved. |
| Time Frame | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Median (Full Range) [days] |
21.0
|
21.6
|
42.0
|
21.0
|
35.0
|
42.0
|
| Title | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline |
|---|---|
| Description | |
| Time Frame | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 23 | 24 | 23 | 24 | 24 | 25 |
| Median (Full Range) [mg/kg/week] |
2.30
|
2.50
|
2.32
|
2.36
|
1.96
|
1.61
|
| Title | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week |
|---|---|
| Description | |
| Time Frame | Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 19 | 24 | 21 | 23 | 23 | 21 |
| Hb at Response Timepoint |
11.49
(0.414)
|
11.40
(0.289)
|
11.32
(0.360)
|
11.47
(0.430)
|
11.62
(0.543)
|
11.43
(0.348)
|
| Change after 1 week |
0.30
(0.579)
|
0.03
(0.562)
|
-0.18
(0.854)
|
0.18
(0.570)
|
-0.26
(0.709)
|
-0.23
(0.394)
|
| Change after 2 weeks |
0.46
(0.685)
|
0.05
(0.634)
|
-0.22
(0.868)
|
0.41
(0.678)
|
-0.34
(0.720)
|
-0.21
(0.707)
|
| Change after 3 weeks |
0.67
(0.635)
|
0.19
(0.720)
|
-0.02
(0.842)
|
0.44
(0.873)
|
-0.31
(0.934)
|
-0.25
(0.682)
|
| Change after 4 weeks |
0.81
(0.642)
|
0.17
(0.968)
|
0.06
(0.767)
|
0.61
(0.859)
|
-0.18
(1.080)
|
-0.24
(0.794)
|
| Change after 5 weeks |
0.99
(0.705)
|
0.20
(1.004)
|
-0.07
(0.701)
|
0.65
(0.883)
|
-0.05
(1.295)
|
0.13
(0.752)
|
| Change after 6 weeks |
1.01
(0.999)
|
0.23
(0.931)
|
0.02
(0.821)
|
0.67
(0.799)
|
0.10
(1.274)
|
-0.01
(0.937)
|
| Change after 7 weeks |
0.97
(0.874)
|
0.21
(0.860)
|
0.40
(0.876)
|
0.87
(0.882)
|
-0.21
(1.255)
|
0.03
(0.830)
|
| Change after 8 weeks |
1.05
(0.852)
|
0.45
(0.827)
|
0.18
(0.820)
|
0.78
(0.820)
|
-0.15
(1.238)
|
-0.03
(1.005)
|
| Change after 9 weeks |
0.88
(0.904)
|
0.59
(0.898)
|
0.22
(1.131)
|
0.79
(0.960)
|
-0.43
(1.075)
|
-0.03
(0.944)
|
| Change after 10 weeks |
0.88
(1.044)
|
0.68
(0.787)
|
0.44
(1.109)
|
1.01
(0.629)
|
-0.22
(1.226)
|
0.26
(1.018)
|
| Change after 11 weeks |
0.89
(1.088)
|
0.59
(0.644)
|
0.39
(0.972)
|
0.82
(0.678)
|
-0.42
(0.966)
|
0.09
(0.974)
|
| Change after 12 weeks |
0.91
(1.007)
|
0.69
(0.474)
|
0.25
(0.966)
|
0.60
(0.745)
|
-0.38
(0.818)
|
0.21
(0.774)
|
| Change after 13 weeks |
1.53
(0.962)
|
0.90
(0.837)
|
0.13
(1.010)
|
0.45
(0.808)
|
-0.58
(0.946)
|
0.33
(0.880)
|
| Change after 14 weeks |
2.16
(0.385)
|
0.94
(0.976)
|
0.18
(0.913)
|
0.37
(0.874)
|
-0.65
(1.079)
|
0.41
(0.778)
|
| Change after 15 weeks |
1.20
(NA)
|
1.50
(NA)
|
0.13
(0.751)
|
0.32
(0.815)
|
-0.67
(1.191)
|
0.18
(0.636)
|
| Change after 16 weeks |
0.08
(0.851)
|
0.21
(0.808)
|
-0.68
(1.262)
|
0.41
(0.524)
|
||
| Change after 17 weeks |
0.12
(0.529)
|
0.18
(0.718)
|
-0.52
(0.984)
|
0.47
(0.751)
|
||
| Change after 18 weeks |
-0.06
(0.704)
|
0.39
(0.763)
|
-0.44
(0.699)
|
0.27
(0.405)
|
||
| Change after 19 weeks |
-0.20
(0.807)
|
0.33
(0.855)
|
-0.31
(0.888)
|
0.26
(0.821)
|
||
| Change after 20 weeks |
-0.50
(0.283)
|
-0.12
(1.035)
|
-0.43
(1.275)
|
0.51
(0.839)
|
||
| Change after 21 weeks |
0.20
(NA)
|
-0.49
(1.146)
|
-0.40
(0.849)
|
0.37
(0.737)
|
||
| Change after 22 weeks |
0.90
(NA)
|
-1.05
(0.480)
|
-0.33
(0.839)
|
0.15
(0.354)
|
||
| Change after 23 weeks |
-1.10
(NA)
|
-0.90
(NA)
|
||||
| Change after 2 weeks posttreatment |
0.49
(1.113)
|
0.21
(0.985)
|
-0.28
(0.614)
|
-0.25
(0.924)
|
-0.61
(1.023)
|
-0.34
(0.562)
|
| Change after 4 weeks posttreatment |
0.21
(1.289)
|
-0.28
(0.902)
|
-0.62
(0.846)
|
-0.80
(0.708)
|
-0.99
(1.296)
|
-0.79
(0.777)
|
| Title | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories |
|---|---|
| Description | |
| Time Frame | Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 19 | 23 | 22 | 23 | 23 | 22 |
| After Response through EoT, Hb Category <11 g/dL |
11.50
(25.937)
|
18.75
(27.254)
|
35.48
(32.727)
|
14.03
(18.311)
|
38.32
(30.175)
|
32.56
(33.384)
|
| After Response through EoT, Hb Category 11-12 g/dL |
31.46
(30.410)
|
48.86
(26.771)
|
46.67
(29.540)
|
41.54
(26.619)
|
44.17
(22.858)
|
47.00
(27.692)
|
| After Response through EoT, Hb Category 11-13 g/dL |
66.73
(27.453)
|
76.05
(26.577)
|
62.10
(31.528)
|
74.96
(24.078)
|
56.92
(27.338)
|
64.39
(32.083)
|
| After Response through EoT, Hb Category 10.5-13 g/dL |
76.80
(23.899)
|
87.20
(20.118)
|
82.69
(25.854)
|
83.50
(21.354)
|
79.01
(23.045)
|
83.97
(26.219)
|
| In Follow Up, Hb Category <11 g/dL |
16.67
(34.300)
|
35.71
(42.258)
|
54.76
(41.547)
|
47.83
(43.896)
|
57.50
(43.755)
|
50.00
(44.096)
|
| In Follow Up, Hb Category 11-12 g/dL |
30.56
(38.877)
|
40.48
(40.679)
|
40.48
(40.679)
|
41.30
(38.883)
|
30.00
(37.697)
|
47.37
(42.406)
|
| In Follow Up, Hb Category 11-13 g/dL |
69.44
(42.492)
|
59.52
(40.679)
|
45.24
(41.547)
|
52.17
(43.896)
|
42.50
(43.755)
|
50.00
(44.096)
|
| In Follow Up, Hb Category 10.5-13 g/dL |
75.00
(39.295)
|
83.33
(32.914)
|
66.67
(36.515)
|
71.74
(39.388)
|
65.00
(43.225)
|
73.68
(34.835)
|
| Title | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 |
|---|---|
| Description | The mean percentage of the scheduled weekly Hb values that were <10.5, >13, and >14 g/dL during Weeks 13-17 and 18-25 is presented. |
| Time Frame | Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. LOCF method was used to impute missing values. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 22 | 24 | 23 | 23 | 22 | 24 |
| Weeks 13-17, Hb <10.5 g/dL |
15.23
(33.893)
|
7.92
(20.212)
|
25.65
(36.752)
|
9.78
(24.885)
|
9.17
(19.174)
|
22.75
(35.995)
|
| Weeks 13-17, Hb >13 g/dL |
25.00
(37.257)
|
7.50
(17.508)
|
4.35
(14.717)
|
18.26
(31.283)
|
2.95
(7.662)
|
0.87
(4.170)
|
| Weeks 13-17, Hb >14 g/dL |
2.73
(9.351)
|
0
(0)
|
0
(0)
|
0.87
(4.170)
|
0
(0)
|
0
(0)
|
| Weeks 18-25, Hb <10.5 g/dL |
21.97
(31.809)
|
9.38
(22.797)
|
23.86
(33.830)
|
16.84
(31.625)
|
||
| Weeks 18-25, Hb >13 g/dL |
2.17
(10.426)
|
5.00
(16.219)
|
3.41
(15.990)
|
3.13
(7.599)
|
||
| Weeks 18-25, Hb >14 g/dL |
0
(0)
|
0
(0)
|
0.57
(2.665)
|
0
(0)
|
| Title | Number (%) of Participants Requiring Rescue Therapy |
|---|---|
| Description | Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron |
| Time Frame | Baseline up to Week 28 (end of study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all participants who received any dose of study drug. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 25 |
| Blood Transfusion |
0
0%
|
2
8.3%
|
0
0%
|
1
4.2%
|
2
8.3%
|
0
0%
|
| ESA |
0
0%
|
1
4.2%
|
0
0%
|
0
0%
|
1
4.2%
|
2
8%
|
| IV Iron |
0
0%
|
1
4.2%
|
0
0%
|
1
4.2%
|
2
8.3%
|
2
8%
|
| Title | Number (%) of Participants Requiring Therapeutic Phlebotomy |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 28 (end of study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all participants who received any dose of study drug. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 25 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 28 (end of study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all participants who received any dose of study drug. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 25 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 |
|---|---|
| Description | Dose changes include dose reductions, dose increases, and dose holds. |
| Time Frame | Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all participants who received any dose of study drug. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 | 25 |
| Dose reduced, Weeks 1-4 |
5
20.8%
|
1
4.2%
|
0
0%
|
2
8.3%
|
1
4.2%
|
0
0%
|
| Dose reduced, Weeks 5-12 |
13
54.2%
|
4
16.7%
|
2
8.3%
|
7
29.2%
|
3
12.5%
|
5
20%
|
| Dose reduced, Weeks 13-16 |
0
0%
|
7
29.2%
|
4
16.7%
|
3
12.5%
|
1
4.2%
|
0
0%
|
| Dose reduced, Weeks 17-24 |
2
8.3%
|
3
12.5%
|
1
4.2%
|
2
8.3%
|
||
| Dose increased, Weeks 1-4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Dose increased, Weeks 5-12 |
10
41.7%
|
11
45.8%
|
14
58.3%
|
9
37.5%
|
9
37.5%
|
15
60%
|
| Dose increased, Weeks 13-16 |
4
16.7%
|
4
16.7%
|
2
8.3%
|
1
4.2%
|
3
12.5%
|
4
16%
|
| Dose increased, Weeks 17-24 |
2
8.3%
|
3
12.5%
|
5
20.8%
|
0
0%
|
||
| Dose held, Weeks 1-4 |
2
8.3%
|
4
16.7%
|
0
0%
|
2
8.3%
|
3
12.5%
|
3
12%
|
| Dose held, Weeks 5-12 |
5
20.8%
|
2
8.3%
|
2
8.3%
|
4
16.7%
|
3
12.5%
|
4
16%
|
| Dose held, Weeks 13-16 |
1
4.2%
|
1
4.2%
|
0
0%
|
1
4.2%
|
2
8.3%
|
0
0%
|
| Dose held, Weeks 17-24 |
1
4.2%
|
1
4.2%
|
3
12.5%
|
0
0%
|
| Title | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) |
|---|---|
| Description | |
| Time Frame | Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 19 | 24 | 21 | 23 | 23 | 21 |
| Weekly Dose |
4.08
(0.952)
|
4.13
(0.944)
|
2.88
(1.721)
|
4.17
(1.119)
|
2.65
(0.886)
|
3.02
(0.876)
|
| Cumulative Dose |
16.86
(17.097)
|
20.05
(15.994)
|
24.41
(23.838)
|
21.21
(18.229)
|
16.57
(12.154)
|
22.16
(17.612)
|
| Title | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) |
|---|---|
| Description | |
| Time Frame | Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population included all participants who received any dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 18 | 23 | 20 | 23 | 22 | 20 |
| 1 week after response |
2.99
(1.16)
|
3.05
(1.13)
|
2.73
(1.56)
|
3.87
(1.28)
|
2.09
(0.89)
|
2.59
(0.90)
|
| 2 weeks after response |
2.64
(1.14)
|
2.86
(1.13)
|
2.63
(1.39)
|
3.85
(1.08)
|
1.97
(0.92)
|
2.50
(1.02)
|
| 3 weeks after response |
2.50
(0.84)
|
2.86
(1.06)
|
2.63
(1.39)
|
3.53
(1.13)
|
1.92
(0.87)
|
2.47
(0.99)
|
| 4 weeks after response |
2.18
(0.82)
|
2.82
(0.91)
|
2.44
(1.13)
|
3.81
(1.36)
|
1.96
(0.95)
|
2.62
(1.14)
|
| 5 weeks after response |
2.32
(0.75)
|
2.73
(0.86)
|
2.54
(1.52)
|
3.61
(1.49)
|
1.97
(0.96)
|
2.57
(1.05)
|
| 6 weeks after response |
2.09
(0.82)
|
2.75
(0.87)
|
2.57
(1.47)
|
3.48
(1.30)
|
1.99
(0.98)
|
2.53
(1.16)
|
| 7 weeks after response |
2.03
(0.69)
|
2.76
(0.90)
|
2.65
(1.51)
|
3.31
(1.29)
|
1.99
(1.00)
|
2.33
(0.94)
|
| 8 weeks after response |
2.01
(0.78)
|
2.84
(0.96)
|
2.60
(1.54)
|
3.21
(1.33)
|
2.07
(1.07)
|
2.14
(0.80)
|
| 9 weeks after response |
2.01
(0.88)
|
2.71
(1.08)
|
2.35
(1.22)
|
3.16
(1.43)
|
2.15
(1.08)
|
2.23
(0.86)
|
| 10 weeks after response |
2.15
(0.79)
|
2.59
(1.00)
|
2.18
(1.29)
|
2.96
(1.36)
|
2.13
(1.09)
|
2.16
(0.89)
|
| 11 weeks after response |
2.13
(0.85)
|
2.72
(1.16)
|
2.18
(1.29)
|
2.77
(1.30)
|
2.02
(0.89)
|
2.14
(0.93)
|
| 12 weeks after response |
2.07
(0.75)
|
2.81
(0.97)
|
2.19
(1.34)
|
2.65
(1.40)
|
1.89
(0.93)
|
1.87
(0.82)
|
| 13 weeks after response |
1.72
(0.85)
|
2.70
(0.43)
|
2.19
(1.34)
|
2.65
(1.42)
|
1.70
(0.58)
|
1.95
(0.83)
|
| 14 weeks after response |
2.87
(NA)
|
2.04
(1.42)
|
2.69
(1.52)
|
1.71
(0.54)
|
1.83
(0.87)
|
|
| 15 weeks after response |
2.04
(1.44)
|
2.68
(1.51)
|
1.70
(0.56)
|
1.85
(0.91)
|
||
| 16 weeks after response |
2.04
(1.44)
|
2.72
(1.62)
|
1.66
(0.53)
|
1.76
(0.72)
|
||
| 17 weeks after response |
2.13
(1.46)
|
2.51
(1.67)
|
1.66
(0.50)
|
1.82
(0.89)
|
||
| 18 weeks after response |
1.53
(0.66)
|
2.43
(1.79)
|
1.57
(0.50)
|
1.83
(0.94)
|
||
| 19 weeks after response |
1.25
(0.39)
|
2.51
(1.94)
|
1.63
(0.58)
|
1.89
(0.98)
|
||
| 20 weeks after response |
1.82
(1.29)
|
1.49
(0.70)
|
1.36
(0.40)
|
|||
| 21 weeks after response |
1.65
(NA)
|
1.13
(0.42)
|
1.36
(0.80)
|
1.28
(0.24)
|
||
| 22 weeks after response |
0.85
(NA)
|
2.04
(NA)
|
| Title | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 |
|---|---|
| Description | Baseline was defined as the mean of the last 3 available values predose. |
| Time Frame | Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. Last-observation-carried-forward (LOCF) method was used to impute missing values. |
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. |
| Measure Participants | 17 | 11 | 10 | 14 | 9 | 13 |
| Baseline |
9.62
(0.92)
|
9.56
(0.43)
|
9.68
(0.41)
|
9.58
(0.86)
|
9.96
(0.51)
|
9.75
(0.63)
|
| Change at Week 16 |
2.42
(1.12)
|
2.32
(1.00)
|
1.85
(1.34)
|
2.21
(1.42)
|
1.37
(0.68)
|
1.42
(1.01)
|
| Change at Week 24 |
1.66
(0.45)
|
1.75
(1.14)
|
1.09
(0.82)
|
1.53
(0.88)
|
Adverse Events
| Time Frame | Baseline up to Week 28 (end of study) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Population included all participants who received any dose of study drug. | |||||||||||
| Arm/Group Title | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW | ||||||
| Arm/Group Description | Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency was reduced from BIW to QW. | ||||||
All Cause Mortality |
||||||||||||
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/24 (12.5%) | 4/24 (16.7%) | 4/24 (16.7%) | 4/24 (16.7%) | 10/24 (41.7%) | 10/25 (40%) | ||||||
| Cardiac disorders | ||||||||||||
| Cardiac Failure Congestive | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 1/24 (4.2%) | 0/24 (0%) | 3/25 (12%) | ||||||
| Cardio-Respiratory Arrest | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
| Acute Myocardial Infarction | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Atrial Fibrillation | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Myocardial Infarction | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Ear and labyrinth disorders | ||||||||||||
| Vertigo | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Pancreatitis | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
| Abdominal Pain Lower | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Diabetic Gastroparesis | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Haematemesis | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
| Pancreatitis Acute | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| General disorders | ||||||||||||
| Death | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Cholecystitis | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Cellulitis | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 2/25 (8%) | ||||||
| Abscess | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Bronchopneumonia | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Pneumonia | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Contusion | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Foreign Body | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Spinal Fracture | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Toxicity To Various Agents | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Hyponatraemia | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 1/24 (4.2%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Diabetic Ketoacidosis | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 1/25 (4%) | ||||||
| Hyperglycaemic Hyperosmolar Nonketotic Syndrome | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Muscular Weakness | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Colon Cancer | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Brain Stem Infarction | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Cerebellar Infarction | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Subarachnoid Haemorrhage | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Syncope | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Renal Failure Acute | 0/24 (0%) | 1/24 (4.2%) | 1/24 (4.2%) | 0/24 (0%) | 1/24 (4.2%) | 1/25 (4%) | ||||||
| Renal Failure Chronic | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Renal Impairment | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Acute Respiratory Failure | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Dyspnoea | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
| Epistaxis | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Pulmonary Embolism | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Pulmonary Oedema | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Respiratory Failure | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Vascular disorders | ||||||||||||
| Hypotension | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/25 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/24 (62.5%) | 15/24 (62.5%) | 10/24 (41.7%) | 10/24 (41.7%) | 11/24 (45.8%) | 10/25 (40%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Nausea | 4/24 (16.7%) | 1/24 (4.2%) | 1/24 (4.2%) | 3/24 (12.5%) | 5/24 (20.8%) | 0/25 (0%) | ||||||
| Diarrhoea | 3/24 (12.5%) | 4/24 (16.7%) | 2/24 (8.3%) | 2/24 (8.3%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Constipation | 2/24 (8.3%) | 2/24 (8.3%) | 1/24 (4.2%) | 0/24 (0%) | 3/24 (12.5%) | 1/25 (4%) | ||||||
| Vomiting | 3/24 (12.5%) | 1/24 (4.2%) | 0/24 (0%) | 2/24 (8.3%) | 2/24 (8.3%) | 0/25 (0%) | ||||||
| General disorders | ||||||||||||
| Oedema Peripheral | 1/24 (4.2%) | 5/24 (20.8%) | 4/24 (16.7%) | 2/24 (8.3%) | 2/24 (8.3%) | 4/25 (16%) | ||||||
| Infections and infestations | ||||||||||||
| Urinary Tract Infection | 0/24 (0%) | 4/24 (16.7%) | 2/24 (8.3%) | 1/24 (4.2%) | 4/24 (16.7%) | 3/25 (12%) | ||||||
| Nasopharyngitis | 2/24 (8.3%) | 2/24 (8.3%) | 2/24 (8.3%) | 2/24 (8.3%) | 3/24 (12.5%) | 2/25 (8%) | ||||||
| Sinusitis | 2/24 (8.3%) | 3/24 (12.5%) | 2/24 (8.3%) | 1/24 (4.2%) | 0/24 (0%) | 0/25 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Dizziness | 2/24 (8.3%) | 1/24 (4.2%) | 3/24 (12.5%) | 1/24 (4.2%) | 2/24 (8.3%) | 0/25 (0%) | ||||||
| Headache | 3/24 (12.5%) | 1/24 (4.2%) | 1/24 (4.2%) | 2/24 (8.3%) | 0/24 (0%) | 1/25 (4%) | ||||||
| Vascular disorders | ||||||||||||
| Hypertension | 4/24 (16.7%) | 1/24 (4.2%) | 1/24 (4.2%) | 2/24 (8.3%) | 2/24 (8.3%) | 1/25 (4%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Clinical Trial Information Desk |
|---|---|
| Organization | FibroGen, Inc. |
| Phone | 415-978-1441 |
Responsible Party:
FibroGen
ClinicalTrials.gov Identifier:
NCT01244763
Other Study ID Numbers:
- FGCL-4592-041
First Posted:
Nov 19, 2010
Last Update Posted:
Feb 10, 2022
Last Verified:
Jan 1, 2022